MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-06 for JANT HCR URINE COMBO PREGNANCY TEST PF-864 manufactured by Jant.
[17261720]
Patient urine pregnancy test # (b)(4). Result was equivocal or undeterminable using jant product # pf864. Lot # 040948, expiration date 08/2015. Result of quantitative hcg was 87,731 miu/ml.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034243 |
| MDR Report Key | 3622311 |
| Date Received | 2014-02-06 |
| Date of Report | 2014-01-15 |
| Date of Event | 2014-01-09 |
| Date Added to Maude | 2014-02-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JANT HCR URINE COMBO PREGNANCY TEST |
| Generic Name | PREGNANCY TEST |
| Product Code | LCX |
| Date Received | 2014-02-06 |
| Catalog Number | PF-864 |
| Lot Number | 040948 |
| Device Expiration Date | 2015-08-01 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JANT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-06 |